FDA.reportPublic FDA data

GERI-TUSSIN DM

Manufacturer
Geri-Care Pharmaceuticals, Corp
Effective date
2019-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:50:25

Label at a glance#

ProductGERI-TUSSIN DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive

Dosage and administration

take every 4 hours as needed, or as directed by a doctor do not take more than 6 doses in 24 hours do not exceed recommended dose Adult and children 12 years and over 2 teaspoonfuls (10 mL) Children under 12 years consult a doctor

Label contents#

Full prescribing information#

Active Ingredients (per teaspoonful=5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr,USP 10 mg

Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Expectorant
Cough Suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Do not use if you are hypersensitive to any of the ingredients.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus) that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or accompanied by fever, rash, or headaches that lasts. These could be signs of a serious condition

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose
Adult and children 12 years and over2 teaspoonfuls (10 mL)
Children under 12 yearsconsult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Red #40, flavors, glucose, glycerin, high fructose corn syrup, menthol, saccharin sodium, sodium benzoate, water

Other information

OTHER SAFETY INFORMATION

  • store at room temperature between 15°-30°C (59° -86°F)
  • protect from freezing.
  • protect from light.
  • Each teaspoon (5 mL) contains: sodium 2 mg.
  • for institutional use only

TAMPER EVIDENT: Do not use this product if breakaway band on cap is broken or missing

SPL UNCLASSIFIED SECTION

Distributed by:

GERI-CARE PHARMACEUTICALS CORP.

1650 63rd Street

Brooklyn, NY 11204

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

660660

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-660-16ML - Milliliter57896-66089ae753d-ccbc-4114-ad8b-fecabb0e8c9912018-06-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-66057896-660-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
FD&C RED NO. 40WZB9127XOAIACT
DEXTROSEIY9XDZ35W2IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
99ffd4b7-a292-5e96-e053-2995a90a7ba56c422b8e-fa7f-a5b2-e053-2991aa0a27d82019-12-18WarningsExact identifier
spl id: 99ffd4b7-a292-5e96-e053-2995a90a7ba5
spl set id: 6c422b8e-fa7f-a5b2-e053-2991aa0a27d8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.